Are you an experienced and motivated Manufacturing Specialist looking to contribute to groundbreaking therapies? At the Princess Máxima Center for pediatric oncology, we are at the forefront of innovation, developing advanced cell and gene therapies with the potential to transform lives. In addition to immune cell engineering, the CGU will focus on the clinical-grade manufacturing of organoids for transplantation purposes. To further shape the CGU in this start-up phase, we are offering an exciting opportunity for a highly motivated Manufacturing Specialist to take on a joint position within the new Cell and Gene Therapy Unit team and the Central Máxima Organoid Biobank. This role provides a unique opportunity to work at the cutting edge of cell therapy and organoid-based regenerative medicine in a dynamic and pioneering environment.
About the Cell and Gene Therapy Unit
The Princess Máxima Center is building a state-of-the-art facility where the primary focus will be the manufacturing of ATMPs. Alongside production, the CGU will play a vital role in translational research to advance and refine innovative therapies. Would you like to know what it’s like to work in our CGU? Rachel shares more about her work in the Cell and Gene Therapy Unit in this article.
Your Key Responsibilities
As a Manufacturing Specialist, you will play a vital role in the production of clinical cell and tissue therapy products, with a particular focus on organoid manufacturing.
Your responsibilities include:
- Performing all tasks related to the manufacturing of clinical-grade cell and tissue therapy products, including the GMP-compliant production of organoids.
- Adapting and optimizing organoid culture protocols to ensure GMP-compliant manufacturing in collaboration with the Clevers and Drost research groups at the Máxima.
- Organizing and executing human clinical biomanufacturing campaigns, ensuring timely delivery of formulated cellular products while meeting regulatory and accreditation standards.
- Assisting in the planning and implementation of cGMP projects at both upstream and downstream levels to support the operational team in delivering advanced therapies to patients.
- Supporting the implementation of the Manufacturing Execution System (MES) as a functional application.
- Training team members on manufacturing processes and liaising with stakeholders during tech transfer activities to integrate new processes.
- Preparing and revising SOPs, Work Instructions, and Batch Records, as well as implementing digital solutions for electronic Batch Record management.
- Contributing to the development of strategies for process innovation and manufacturing improvements.
- Identifying opportunities for process optimization and implementing enhancements.
- Collaborating closely with QA colleagues to address manufacturing deviations and propose corrective and preventive actions (CAPA).
- Taking an active role in the process development of new therapies and translating research advancements into clinical products.
Your Profile
You are an analytical and resourceful professional with a passion for innovation in cell therapy and regenerative medicine. You thrive in a multidisciplinary team and are motivated to contribute to the advancement of pioneering therapies.
Additionally, you bring:
- A university degree in Biomedical, Life Sciences, or a related field.
- Experience in clinical cell therapy product manufacturing, particularly with organoids, HSCTs, CAR-T, T cells, and gene editing, as well as extensive experience in aseptic techniques and cGMP cell culture. Prior experience with aseptic isolators is desirable.
- Familiarity with MES and electronic quality systems.
- Solid knowledge of the EU regulatory and accreditation framework for cellular therapy product manufacturing.
- Experience in generating SOPs, batch manufacturing records (BMRs), and other documentation for clinical manufacturing.
- A combination of analytical thinking and hands-on problem-solving skills, with the ability to manage a dynamic workload.
- Strong interpersonal skills, fostering collaboration and effective teamwork.
- A proactive and innovative mindset, with the ability to develop creative solutions for complex challenges.
- Excellent verbal and written communication skills in English; proficiency in Dutch is a valuable asset.
Working at the Princess Máxima Center
We offer a full-time position (based on 36 hours a week) in a very stimulating and interactive environment. The contract will be initially for one year, with the possibility to extend upon satisfaction. Your gross monthly salary (FWG 55) will be based on your experience and background and will include 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’.
If you do not yet fully meet all the job requirements but are motivated and eager to learn, we still encourage you to apply! In that case, your salary will start in FWG 50.
The Princess Máxima Center
The Princess Máxima Center for Pediatric Oncology is an integrated hospital and research institute, which integrates healthcare, research and education on pediatric cancer, in a single location in Utrecht. Our institute aims to provide the highest level of care for all children with cancer, with optimal quality of life. The center brings together the best possible care and scientific research, creating a unique interdisciplinary institute for pediatric oncology in Europe.
Contact and application
You can apply for this position by pressing the apply button on this screen. May we invite you to apply as soon as possible, since we will close the vacancy when we have found a suitable candidate. For more information about this position, or to arrange an informal chat, please contact: Adeel Saleem, Cell and Gene Therapy Unit.
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